Obtaining measurements of muscle reflexes for diagnosis of patient symptoms

ABSTRACT

A system and method is disclosed for measuring muscle reflexes (e.g., a bulbocavernosus reflex) as a tool for identifying/diagnosing dysfunctions (e.g., spinal cord abnormalities, bladder voiding dysfunction, and sexual organ dysfunction) non-invasively by using mechanical stimulation. The system and method includes a probe having a predetermined patient contacting portion, wherein when the contacting portion is moved into contact with a particular area of the patient (e.g., the patient&#39;s genitals), the contact induces a muscle reflex. The probe detects the pressure resulting from the contacting portion being abruptly and forcibly brought into contact with the particular area. Such detection is used to electronically initiate capture of electrical responses from a plurality of electrodes placed on the patient&#39;s skin in proximity to the particular area. Such electrical responses are processed to determine characteristics of the patient&#39;s reflexes of one or more muscles adjacent to the electrodes.

RELATED APPLICATIONS

The present application claims the benefit of U.S. Provisional PatentApplication No. 60/975,056 filed Sep. 25, 2007 which is incorporated byreference herein in its entirety.

RELATED FIELD OF THE INVENTION

The present disclosure relates to obtaining and processing dataindicative muscle reflexes for screening and/or diagnosing a patient,and especially for obtaining and processing data indicative of reflexesfrom the bulbospongiosus muscle. In particular, the present disclosuredescribes a novel electromechanical probe for stimulating thebulbospongiosus muscle, and consequently identifying a time of thestimulation so that electrical responses from electrodes on thepatient's skin can be identified for analysis.

BACKGROUND

The bulbospongiosus muscle is one of the superficial muscles of theperineum. This muscle is innervated by the deep/muscular branch of theperineal nerve, which is a branch of the pudendal nerve. This muscle hasa slightly different origin, insertion and function in males andfemales. In both sexes, however, bulbospongiosus muscle is important tonormal sexual function and feelings, as well as urinary function. Inmales the bulbospongiosus muscle contributes to erection, ejaculation,and the feelings of orgasm. In females bulbospongiosus muscle closes thevagina and contributes to the feelings of orgasm.

The bulbocavernosus reflex (BCR) is a distinct, automatic (reflex)contraction of the rectum (part of the bowel) that occurs when the tipof the penis (in a man) or clitoris (in a woman) is squeezed orstimulated. In more technical terms, the bulbocavernosus reflex is amulti-synaptic reflex, and measurements of this reflex can provideindications of various neurological abnormalities in and around thepelvic floor, and the lower spinal region of a patient. For example, theintegrity of afferent and efferent segments through sacral spinalsegments (S2-S4) and pudendal nerve may be determined by such BCRmeasurements. Additionally, several levels of BCR abnormalities havebeen reported in cases with impotence when cauda equina or conusmedullaris lesions are present, or when neurogenic bladder related topolyneuropathy is detected. Such BCR abnormalities appear as no BCRresponse, a prolonged latency in BCR response, or a temporal latencydispersion occurring in repetitive measurements. Moreover, a BCRresponse, if prolonged, can be an indication of pelvic nerve damage inpatients with pelvic floor disorders.

It is known to use measurements of the BCR for diagnosis and treatmentof various pelvic floor disorders, including those disorders mentionedabove. Such measurements may be collected from, e.g., urethral and/oranal sphincters after stimulation of the dorsal nerve of the penis orclitoris via activation of electrodes appropriately attached to apatient. Additionally, such measurements have been obtained using EMG(electromyogram) testing. The following references are fullyincorporated herein by reference for further description of EMG and theuse of electrodes for diagnosing patient disorders:

-   U.S. Pat. No. 6,047,202 which discloses an electrode and array    thereof for collecting surface electromyographic signals.-   D. Prutchi in the publication “A High-Resolution Large Array (HRLA)    EMG System” published September 1995 in Med. Eng. Phys., Vol. 17,    442-454. Prutchi describes a bracelet which may be wrapped about a    body limb and which contains 256 surface electrodes to record the    electrical activity of underlying muscles. The electrodes are    arranged in eight groups of thirty-two electrode linear arrays    directly connected to buffer boards in close proximity of the    electrodes. Further processing of the electrical signals is    performed to provide a desired signal analysis, in this instance    primarily being concerned with the bidirectional propagation of a    compound potential in a single muscle in the upper arm of a human    subject or a histogram of total power contribution from active    fibers in a subject muscle, both being presented in charted format.-   U.S. Pat. No. 5,086,779 to DeLuca, et al., describes a back analysis    system of plural electrodes coupled to a computer system for    processing the signals and to provide graphical representations of    results. DeLuca's invention relates primarily to isolating    particular muscle groups by the use of support and restraint devices    which limit the movement of the patient's torso in predetermined    patterns correlated to the desired muscle groups. DeLuca's electrode    array consists of separate electrodes individually placed at desired    locations on a patient's back.-   U.S. Pat. No. 5,058,602 to Brody describes a method of    electromyographic scanning of paravertebral muscles comprising    measuring electrical potentials bilaterally across segments of the    spine. Readings are categorized into different patterns which are    indicative of different muscular conditions. Brody suggests    equipment useful within his described techniques as an available EMG    scanner having electrodes spaced 2.5 cm apart and a computer    component, but provides few details on the equipment or an    indication of usefulness for isolating certain muscles or muscle    groups.-   U.S. Pat. No. 5,318,039 to Kadefors, et al., describes a method and    apparatus for detecting electromyographic signals, processing them    and providing an indication of the change of the signal from a    predetermined norm. Kadefors' electrode system comprises three    electrodes, one of which is a reference marker. This electronic    apparatus, in essence, includes a sample and hold function in which    current responses can be compared to earlier responses and an    indication provided based on the differences detected.-   U.S. Pat. No. 5,505,208 to Toormin, et al., describes a method for    determining the status of back muscles wherein EMG signals are    monitored from a number of electrodes placed in a pattern on a    patient's back, the activity of each electrode is determined and the    results stored. A database of results provides a standard from which    comparisons can be made to determine deviations or abnormalities, as    a device for the care and management of the patient's dysfunction.-   U.S. Pat. No. 5,513,651 to Cusimano, et al., describes a portable    electronic instrument for monitoring muscle activity, using standard    ECG electrodes and a computer for analyzing the detected signals.    The electrodes are applied individually at predetermined locations    and a range of motion device is employed to generate signals related    to a particular muscle group. Output plots are produced to provide    an indication of results, apparently in the form of printouts of    information reflecting any deviations from the norm of expected    muscle activity.

Additional prior art references describing the use of thebulbocavernosus reflex for assessing patient dysfunctions are asfollows, these references being fully incorporated herein by referenceas well:

-   Sarica Y, Karacan I, “Bulbocavernosus reflex to somatic and visceral    nerve stimulation in normal subjects and in diabetics with erectile    impotence”, Journal of Urology, July 1987; 138 (1): 55-8;-   Ertekin C, Akyurekli O, Gurses A N, Turgut H, “The value of    somatosensory-evoked potentials and bulbocavernosus reflex in    patients with impotence”, Acta Neurol Scand., January 1985; 71 (1):    48-53;-   Ziemann U, Reimers C D. “Anal sphincter electromyography,    bulbocavernosus reflex and pudendal somatosensory evoked potentials    in diagnosis of neurogenic lumbosacral lesions with disorders of    bladder and large intestine emptying and erectile dysfunction”,    Nervenarzt, February 1996; 67 (2): 140-6;-   Lavoisier P, Proulx J, Courtois F, De Carufel F, “Bulbocavernosus    reflex: its validity as a diagnostic test of neurogenic impotence”,    Journal of Urology, February 1989; 141 (2): 311-4;-   Vodusek D B, Janko M, Lokar J., “EMG, single fibre EMG and sacral    reflexes in assessment of sacral nervous system lesions”, Journal of    Neurological Neurosurgery Psychiatry, November 1982; 45 (11):    1064-6.

However, prior art procedures and apparatuses for obtaining such BCRmeasurements have been less than satisfactory, e.g., in their ease ofuse, and the discomfort caused to patients. Accordingly, it would beadvantageous to have a non-invasive method and system for accuratelydetecting characteristics of the BCR response, such as latency inresponse, lack of response, abnormal reflex contractions, wherein suchcharacteristics of the BCR are correlated with likely physiologicaland/or neurological dysfunctions.

SUMMARY

A system and method is disclosed herein for measuring muscle reflexes(e.g., a bulbocavernosus reflex) as a tool for identifying/diagnosingdysfunctions such as spinal cord abnormalities (e.g., in segments S2thru S4), bladder voiding dysfunction, and sexual organ dysfunction. Inparticular, the novel screening system and method (referred to as a“screening system and method” herein) disclosed herein provides anon-invasive measurement of the muscle reflex using mechanicalstimulation. Such non-invasive mechanical stimulation is advantageousbecause it is less painful to the patient than prior art measurementtechniques, and in certain instances easier to obtain reflexmeasurements than prior art techniques for measuring a patient's musclereflexes. More particularly, a probe is provided that includes apredetermined contacting portion for contacting the patient, whereinwhen the contacting portion of the probe is moved into contact with aparticular area of the patient (e.g., the patient's genitals), thecontact induces a reflex in one or more of the patient's muscles. Thus,the contacting portion of the probe provides a mechanical stimulus forinducing the patient reflex. In one embodiment, the probe detects thepressure resulting from the contacting portion of the probe beingabruptly and forcibly brought into contact with the particular area ofthe patient's skin, wherein such detection is used to electronicallyinitiate the capture of electrical responses from a plurality ofelectrodes placed on the patient's skin in proximity to the particulararea. Such electrical responses can then be processed to providecharacteristics of the patient's reflexes of one or more musclesadjacent to the electrodes.

In one embodiment of the probe, the patient contacting portion isdetachable from the remainder of the probe so that for differentpatients different patient contacting portions are used. That is, theprobe may be reusable with a plurality of patients except for thepatient contacting portion which is replaceable between patients.Moreover, the patient contacting portion (or the probe itself if it isnon-usable with different patients) may include an electronic device andnon-volatile data storage for identifying whether the probe can be usedfor the data capture (and subsequent processing) of electrical responsesindicative of muscle reflex contraction.

In one particularly important embodiment, the screening system andmethod disclosed herein measures the bulbocavernosus reflex response inunits of milliseconds when this reflex is induced from the activation ofthe bulbospongiosus superficial muscle of the perineum via mechanicalstimulation of the clitoris or penis. The resulting reflex measurementsmay be used for detecting abnormalities in the BCR such as no BCRresponse, a prolonged latency in BCR response, a prolonged BCR response,or a temporal latency dispersion occurring in repetitive measurements.As indicated above, such BCR abnormalities may be indicative of variouspatient dysfunctions, such as spinal cord damage in segments S2 throughS4, urinary voiding dysfunctions, and/or sexual organ dysfunctions(e.g., impotence).

In one embodiment of the novel screening system and method disclosedherein, a prolonged bulbocavernosus reflex (e.g., more than 45milliseconds), or an excessive latency in reflex response (e.g., morethan 45 milliseconds) is considered a sign of neurological diseaseand/or neurological dysfunction. For example, a prolonged BCR responsecan be an indication of pelvic nerve damage in patients with pelvicfloor disorders. Accordingly, results from the present screening systemand method can be used in diagnosis and treatment of pelvic floordisorders.

The system and method disclosed herein includes components for EMG(electromyogram) testing to determine nerve and muscle function as aresult of mechanical stimulation. In particular, such components includeelectrodes for measuring the bulbocavernosus reflex. Such electrodesinclude a reference electrode and a pair of sensing electrodes. Thereference electrode applies a small voltage (e.g., a range of 1.0 to 3.5volts DC, but more preferably 1.25 volts DC) to the skin of a patientduring, e.g., mechanical stimulation of the penis or clitoris, the pairof sensing electrodes is used to detect the actual bulbocavernosusmuscle contraction or reflex due to the mechanical stimulation. In afirst operation of the electrodes 2 and 4, the voltage applied by thereference electrode induces a small electrical current that is generallybelieved to be in a range of 5 microamperes to 9 microamperes, to flowthrough the patient's skin. This range in current is based on a presumedskin resistance of 1-10 meg-ohms, as well as the placement of thereference and sensing electrodes. In particular, in one preferredembodiment, the reference and sensing electrodes are pairwise separatedby, e.g., ½ to 1½ inches (more preferably 1 inch) in an equilateraltriangular pattern or another non-collinear arrangement. However, it iswithin the scope of the present disclosure that other voltages inaddition to or alternatively to the 3.3 volts may be applied to thereference electrode. In particular, such reference voltages may bechanged from one activation of the screening system and method toanother activation.

In another embodiment of the operation of the electrodes 2 and 4,instead of the reference electrode 4 providing a current for flowingthrough the patient to the sensing electrodes 2, the reference electrode4 is used to adjust the voltage potential of the patient. In oneembodiment, the output from the DC voltage source 42 to the electrode 4is adjusted to provide the reference electrode 4 with a voltagepotential in a predetermined range such as ±1.25 volts. When thepotential voltage at the reference electrode 4 is adjusted to such apredetermined range, the potential voltage of the patient (at least inthe skin area of the muscle response being measured) will not varysubstantially from this predetermined range. As one skilled in the artwill understand, in order for the SEMG 35 to effectively determinevoltage differences between the sensor electrodes 2, the voltagesmeasured from the electrodes 2 must be within a predetermined rangedependent on the particular electrical characteristics of the SEMG 35.Accordingly, since a patient may initially have an unacceptably widerange of voltage potentials (e.g., ±1,000 volts) due to, e.g., staticelectricity, and/or being in proximity to an electrical currentgenerating source, this reference electrode voltage is determined byadjusting the electrical output of the DC voltage source 42 to insurethe reference electrode 4 has a voltage within a predetermined range sothat the voltages at the electrodes 2 can be expected to be within anacceptable range for the particular SEMG 35 being used. In oneembodiment, the range of acceptable voltages to the SEMG 35 from theelectrodes 2 is ±3.3 volts. In one embodiment, the sensing electrodesmay be positioned on the patient's skin at the 9 O'clock and 3 O'clockposition around the patient's rectum as shown in FIG. 2, wherein thesensing electrodes may be within, e.g., a range of one to two inchesfrom the patient's rectum. Additionally, the reference electrode may bepositioned on the patient's inner thigh, e.g., approximately four toeight inches from the patient's rectum.

In the first operation of the electrodes 2 and 4, the current induced toflow through the patient's skin (by activation of the referenceelectrode positioned as described above), in turn, causes a very smallvoltage potential to develop between the sensing electrodes. In thesecond operation the electrodes 2 and 4, a small electrical potential isgenerated by the muscle cells when these cells contract. Regardless ofthe which operation of the electrodes 2 and 4 is used, the smallpotential difference in voltage between the sensing electrodes isamplified to a usable level using an instrumentation amplifier, or anamplifier and a (high pass) filter combination. This circuit utilizes astandard surface EMG amplification circuit with a gain of 6174.72, andthen summed (mixed) with some portion of the amplified potentialdifference between the sensing electrodes.

An embodiment of the screening system and method may also include one ormore diagnostic computational models for receiving analyticalinformation generated from the signals output by the sensing electrodes,and, e.g., an indication of patient symptoms for determining one or morelikely patient diagnoses. In particular, such models may receive thefollowing analytical information: no BCR response, a prolonged latencyin BCR response, a prolonged BCR response, a temporal latencydispersion, an amplitude of the BCR, an integral of a graph of the BCR,etc.

Moreover, it is within the scope of the present disclosure that anembodiment of the screening system and method may be utilized forreceiving and analyzing electrical signals indicative of reflexes fromother patient bodily areas, such as the knee (patellar reflexes), andintravaginal stimulation.

Additional features and benefits of the present disclosure are disclosedin the accompanying figures and description hereinbelow. Such additionalfeatures and benefits, to the extent they are novel and non-obvious, areconsidered a proper subject matter for patent protection regardless ofwhere their disclosure is provided in this Summary section.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of the novel screening system and methoddisclosed herein. In particular, FIG. 1 shows the high level componentsof the novel apparatus for obtaining BCR measurements from electrodes(not shown) that are to be placed on a patient, wherein an exploded viewof the probe 10 is shown.

FIG. 2 shows one arrangement of the sensing electrodes 2 and thereference electrode 4 on a female patient for obtaining electricalsignals for measuring BCR by the novel screening system and methoddisclosed herein.

FIG. 3 shows the components of another embodiment of the novel screeningsystem and method, wherein an exploded view of the probe 10 a is shown.

FIG. 4 shows the embodiment of FIG. 3 with the probe 10 a fullyassembled.

FIG. 5 shows an output screen for viewing BCR measurements, inparticular, the following are shown: the magnitude and location of theapplied stimulus (via the probe 10), the magnitude and time for a timeseries of responses to the stimulus, the time delay between theapplication of the stimulus and corresponding response(s).

FIG. 6 shows a block diagram of another embodiment of the screeningsystem and method disclosed herein.

DETAILED DESCRIPTION

The screening system and method disclosed herein includes mechanicalstimulation of the penis or clitoris performed by a novel probe 10,wherein a first embodiment of this probe is shown in FIG. 1. In theembodiment of the probe 10 of FIG. 1 (shown in an exploded view), theprobe includes a housing or handle 11, a piezoelectric disk or diaphragm12, a stimulus plunger 13, a plunger housing 14, and a compressionspring 15. When the probe 10 of FIG. 1 is assembled, the shaft 18 (ofthe stimulus plunger 13) extends through the bore or opening 22 of theplunger housing 14; however, since the expanded portion 24 of thestimulus plunger 13 can not fit through the opening 22, this preventsthis plunger from sliding out the opening 22. The piezoelectric disk 12seats against a stop 26 within the generally cylindrical interior of thehousing 11. The compression spring 15 biases an opposing end 30 of thestimulus plunger 13 away from contact with the piezoelectric disk 12.The piezoelectric disk 12 is electrically activated by a power sourcethat may be internal or external to the probe 10. FIG. 1 shows anembodiment of the probe 10 wherein there is a battery 17 within thehousing 11 for energizing the disk 12 in a conventional manner as one ofordinary skill in the art will understand. Additionally, there is anelectrical conductor 19 in the probe 10 between the disk 12 and anexternal electrical conductor 38, wherein signals indicative of theopposing end 30 contacting the disk are conducted by the conductors 19and 38 for amplification and establishing a commencement of data capturefrom the electrodes 2 as will be described in further detailhereinbelow. Note that the use of a piezoelectric disk may be importantto embodiments of the probe 10 over other mechanisms for detecting whento commence data capture from the electrodes 2 since a piezoelectricdisc has a very quick response time that is required due to the verybrief response times encountered by the BCR (e.g., generally less than200 milliseconds).

At a very high level, the probe 10 is used to contact the patient'sclitoris or penis and in particular, a probe tip 34 (referred to moregenerally hereinabove as a “patient contacting portion”) contacts thepatient's clitoris or penis for thereby inducing a patient reflexresponse. The detection of the probe tip 34 contacting the clitoris orpenis is accomplished by the probe 10 outputting an electrical signalindicative of the stimulus plunger 13 contacting the piezoelectric disk12. The BCR in response to such contact is then detected by electricalsignals output from properly positioned electrodes 2 on the patient'sskin. Subsequently, such signals are amplified and then analyzed fordetermining/identifying characteristics of the amplified signals (and/ora graph thereof), wherein such characteristics may be used foridentifying patient ailments and/or providing a patient diagnosis.

The compression spring 15, and plunger housing 14 restrain the stimulusplunger 13 in such a way that it can only move along the axis 16, and inparticular, towards the piezoelectric disk 12 when the stimulus plungertip 34 comes in contact with another object (e.g., a patient) withsufficient force to overcome the opposing force of the compressionspring 15. Accordingly, when the stimulus plunger tip 34 comes incontact with a patient with such force so that the stimulus plunger 13comes in contact with the piezoelectric disk 12 (while the disk iselectrically activated), the disk distorts its shape (e.g., bends), andthe mechanical stress caused by the stimulus plunger 13 contacting thepiezoelectric disk 12 causes an electrical charge to develop on thesurface of the piezoelectric disk 12. Since the disk 12 is electricallyconnected to an amplifier 36 (via the connection 19 and the externalconductor 38), the electrical charge induced on the disk is detected bythe amplifier for amplification (and at least in some embodiments,filtered as well via a high pass filter). Thus, the disk 12 functions asa sensor for detecting contact between a patient and the tip 34.However, alternative sensors may be used to detect the transfer ofpressure from the tip 34 to the disk 12. In particular, the opposing end30 may include a pressure sensitive switch (not shown) for detectingcontact with the disk 12.

In one preferred embodiment, the probe 10 may be handheld by an operatorfor placing the probe in contact with a patient's penis or clitoris forinitiating bulbocavernosus reflex. Moreover, in one preferredembodiment, the contact of the probe tip 34 with the patient's clitorisor penis is performed by an abrupt, non-invasive, pressure inducingmotion that is preferably somewhat unexpected by the patient. Such amotion may be similar to inducing patellar reflexes during anexamination of a patient's knee reflexes.

A battery 17 (e.g., internal to the probe), or a transformer (e.g.,external to the probe, and not shown) may be used to electricallyactivate the disk 12 for detecting contact by the end 30 when genitalsimulation is performed via contact with the tip 34 of the shaft 18(which extends through the bore 22).

Although such piezoelectric disks 12 may generate mechanical or pressurevibrations (i.e., oscillations in directions coincident with axis 16,FIG. 1), when electrically activated, wherein such vibrations may betransmitted to the tip 34, in at least some embodiments of the probe 10,any such vibrations are of substantially no consequence in inducing thegenital stimulation. Said another way, the piezoelectric disk 12 is usedonly as a sensor for detecting the movement of the tip 34 when itcontacts the patient for genital stimulation. However,additional/alternative methods of inducing such a BCR is also within thescope of embodiments disclosed herein. For example, the probe tip 34 maybe vibratory such that the tip may first come in contact with thepatient's clitoris or penis, and then commences a vibratory motion,wherein at the commencement of the vibratory motion, the probe 10 mayoutput a signal indicative of the commencement of the vibratory motion.In particular, such contact prior to the on set of the vibratory motionmay be relatively gentle and non-abrupt. It is believed that suchvibratory motion may be provided by a piezoelectric disk 12 ofappropriate manufacture.

The amplifier 36 (e.g., an EMG amplifier and high pass filter) amplifiesthe detected charge on the disk 12 induced by genital stimulation. Theamplifier 36 responds by outputting a corresponding amplified responsesignal on the transmission cable 44 for transmission to a computer 40.The computer 40 is programmed to receive the probe 10 amplified signalas input, and assuming an electrical potential is being concurrentlyapplied to the reference electrode 4 (e.g., via the DC voltage source42), the amplified probe signal on the cable 44 act as a trigger toactivate a signal conversion process 48 for commencing to sample theamplified electrode 2 signals output by the amplifier 36 via the surfaceelectromyography (SEMG) unit 35. The computer 40 then converts theamplified signals from the electrodes 2 into a time series of numbersrepresenting the magnitudes of the samples. In particular, the amplifiedelectrode signals output on connection 46 a are amplifications of thedifferences of signals derived from the sensing electrodes 2 (FIGS. 1 &2) on wires 46 b. In particular, the SEMG 35 receives the voltagesignals from both of the electrodes 2 and forms a difference signal thatis output to the amplifier 36.

As shown in FIG. 2, the sensing electrodes 2 may be placed atpredetermined locations on a patient's body, e.g., at the 9 and 3O'clock positions around a patient's rectum. Additionally, the referenceelectrode 4 may be positioned as also shown in FIG. 2 (e.g., in thepatient's crotch area nearer to the genital area than the electrodes 2),or in some embodiments, the reference electrode 4 may be positioned onthe patient's inner thigh (e.g., within six inches of the patient'sgenital area, and more preferably within 4 inches).

Note that the probe 10 (and in some embodiments, only the probe tip, asdiscussed in other sections hereinbelow) may be a single patient usedevice (i.e., non-reusable), e.g., the probe (or probe tip) is, in atleast preferred embodiments, deactivated after it has been attached tothe computer 40 for, e.g., an extended time period of such as 30minutes. Such an extended time period gives an operator of the screeningsystem and method ample time to obtain measurements of thebulbocavernosus reflex desired for the screening process. Note that whenthe probe 10 is battery powered such deactivation may be provided by adraining of the one or more batteries; e.g., once the probe isactivated, current continues to flow from the one or more batteriesuntil the batteries cannot power the probe. However, it is within thescope of the present disclosure that other methods of deactivating suchbatteries may be used, such as having an operator manipulate adeactivation switch that permanently disconnects the electrical power tothe piezoelectric disk 12, or by providing an electronic timer in theprobe 10 that activates with the first activation of the probe anddeactivates the probe after a predetermined time has elapsed.

Amplified voltage signals derived from the difference of the signalsoutput by the sensing electrodes 2 are provided to the computer 40, andin particularly, to the signal conversion process 48. The amplifiedvoltage signals includes signals representative of the potential(voltage) differences between the sensing electrodes 2 as determined bythe SEMG 35.

However, in an alternative embodiment, the wires 46 b may connectdirectly to the amplifier 36 for simply amplifying and outputting eachof its input electrode 2 signals. In such an embodiment, the signalconversion process 48 computes values representative of the potentialdifferences between the sensing electrodes 2. Note that the SEMG 35 isnot required in this embodiment.

Using the output from the amplifier 36, the signal conversion process 48performs an analog to digital conversion, wherein the signals on theconnection 46 a are sampled, digitized, and then the digitized samplesare input to a computational procedure for generating a time series ofrecords (e.g., a series of measurement records) representing themagnitude of the amplified signals over a predetermined elapsed time.More specifically, for each sampling period, the connection 46 a issampled, the obtained sample is used to determine a number in apredetermined range of, e.g., 0 to 4096, wherein the greater the number,the greater BCR, and wherein such numbers from different referenceelectrode voltages can be reliably compared, summed, averaged orotherwise combined if desired. Moreover, the values in thispredetermined range may be then normalized to the range 0.0 to 1.0, asone of ordinary skill in the art will understand.

However, it is within the scope of the present disclosure that, insteadof the resulting time series of BCR numbers being monotonic with theBCR, such numbers may be inversely related to the BCR. Accordingly,instead of 1.0 being indicative of a maximal BCR response as is computedin the steps above, 0.0 would be indicative of the maximal BCR response.

The time period between samplings may be, e.g., 1.0 millisecond,although alternative time periods that are smaller or larger are withinthe scope of the present disclosure.

In one embodiment of the screening system and method, an analog todigital converter separate from the computer 40 may receive the signalsfrom the amplifier 36 for performing the signal conversion process 48.

However, regardless of where the analog to digital conversion isperformed, subsequently the analysis process 60 described hereinbelow isperformed.

The analysis process 60 may be instrumental in determining BCR patientdata to be output to the display device 52 (FIG. 1), to a database (notshown), and/or to a report generator (not shown). In particular, theanalysis process 60 may determine one or more of the following BCRrelated measures when provided with digital data output from the signalconversion process 48:

-   -   (a) a latency between the detection of the response signal on        cable 44, and commencement of the BCR signals from the        electrodes 2,    -   (b) a duration of the BCR signals from the electrodes 2,    -   (c) a value indicative of a magnitude or strength of the BCR,        and/or    -   (d) an attenuation in the magnitude or strength of the BCR        (e.g., in comparison to an expected magnitude or strength).        Additionally, as described hereinbelow, the analysis process 60        may also determine associations between, e.g., values such        as (a) through (d) immediately above, and likely a diagnosis of        a patient's symptoms.

In order to more fully describe the processing and output of theanalysis process 60, a description of a representative embodiment ofoutput 56 (FIG. 1, and more particularly FIG. 5) from the analysisprocess is now described, wherein this output 56 is provided to acomputer display device 52 operatively connected to the computer 40. Inparticular, referring to FIG. 5, a graph 62 may be displayed, whereinthe horizontal (X) axis is elapsed time (in milliseconds), and thevertical axis represents signal magnitude values (preferably normalizedto the range 0.0 to 1.0). A time value identified by the vertical line64 on the graph 62 represents the detected application of the patientstimulus from the probe 10 as determined from the response signal on thecable 44. A subsequent time is identified by the vertical line 66 whichrepresents the initial onset of the BCR in response to this stimulus.The Y (vertical) axis of the graph 62 represents the magnitude of adetected muscle (BCR) contractions. This magnitude is normalized in therange of 0.0 to 1.0 with 1.0 being the highest magnitude. The timeseries of normalized BCR response numbers is represented by thegraphical signature 68. The horizontal line 72 is a reference line tofacilitate viewing the graph 62. The auxiliary trace 74 is also foroperator reference as well. In particular, the trace 74 provides theoperator with a visual indication of all changes in voltage signalsreceived from the electrodes 2 and the probe signals received on cable44, wherein each change is shown by an upward movement in the trace 74.The values of the trace 74 may be computed as follows: Y_(n)=X_(n)·Gwhere G=1/4096, and X_(n) is the n^(th) BCR response value, and Y_(n) isthe normalized representation of the incoming time series, X_(n) is theinput signal, G is the constant and n is the time start to stop.

In one embodiment, the position of the line 66 is manually assigned byan operator, wherein, e.g., the operator is able to set (and/or selectand drag) this line to the position the operator determines is mostindicative the onset of the BCR. However, in an alternative embodiment,the position of the line 66 may be estimated by the screening system andmethod, e.g., by identifying an initial time where the graphicalsignature 68 remains above a predetermined threshold for a predeterminedelapsed time.

A patient symptom can be entered in the interaction box 76, and thecollected patient data, and/or measurements/characteristics derivedtherefrom, can be associated with this symptom. Accordingly, once anactual diagnosis of the cause of the symptom is determined for each of aplurality of patients, associations may be obtained between: (i) suchactual diagnoses, and (ii) the symptoms and correspondingmeasurements/characteristics of the collected patient data (e.g.,patient graphical signatures 68). In particular, such associations maybecome the basis for one or more predictive models for predicting alikely (if any) patient abnormality/diagnosis, wherein such associationsmay be formed by one or more of: a statistical method (e.g., aregression technique), a learning system (e.g., a vector machine, and anartificial neural network), and/or a pattern matching system (e.g., afuzzy logic system, etc.). In particular, it is believed that suchassociations may be based substantially on the symptom identificationtogether with one or more of the following BCR measurements:

-   -   (a) a latency between the graphical signature 68 (equivalently,        the BCR signals from the electrodes 2), and the detection of the        response signal on cable 44,    -   (b) a duration of the graphical signature 68 (equivalently, the        BCR signals from the electrodes 2),    -   (c) a magnitude of the graphical signature 68 (equivalently, the        BCR signals from the electrodes 2),    -   (d) an attenuation in the magnitude of the graphical signature        68 (equivalently, the BCR signals from the electrodes 2),        wherein such attenuation is, e.g., in comparison to an expected        magnitude, and/or    -   (e) no detectable graphical signature 68 (equivalently, the BCR        signals from the electrodes 2).

Alternatively/additionally, the resulting time series of the digitaldata stream from the signal conversion process 48 can be input to anembodiment of analysis process 60 for hypothesizing a diagnosis for(any) one or more of sexual, lower spinal, and/or urologicaldysfunctions. Such hypotheses may be generated by one or more hypothesisgenerating predictive models which are described hereinbelow.

Of course, if none of the models identify a likely diagnosis, then itmay concluded that the patient is not likely to have dysfunctions, suchas sacral cord lesions, or prudential neuropathy (impotence, chronicback pain, fecal incontinence), resulting from lack of sacral plexusintegrity.

In one such predictive model, a prolonged bulbocavernosus reflex of morethan 45 msec., such as is shown in FIG. 5, may be considered indicativeof a neurological disorder. More precisely, such a model may hypothesizeone of the following disorders: sacral cord lesions, prudendalneuropathy (impotence, chronic back pain or disc disease), and lesionsof the cauda equine. In one embodiment, prolonged such bulbocavernosusreflexes are determined by a calibration or training process, whereintime series BCR data is obtained from patients with such neurologicaldisorders, and such data is used for determining parameters indicativeof such disorders.

Additionally, such a model (or another model) may also identify anabnormal BCR latency, wherein such latency (e.g., in a range of 50+msec.) may be indicative of the following disorders: diabeticneuropathy, or other, neurogenic disease process.

Moreover, such a model (or another model) may also provide outputcorresponding to an indication of a substantial absence or attenuationof the BCR within the predetermined sample time period for sampling thesignals from the electrodes 2. In particular, such BCR absence orattenuation may be indicative of the following symptoms: sexualdysfunction, voiding dysfunction, and bowel dysfunction. Accordingly,the following may be considered likely diagnoses: decreased or absentsacral plexis response. Note that attenuation of the BCR in a graphicalsignature 68 also may be quantified as no bulbocavernosus response,particularly if such attenuation is below, e.g., a predeterminedthreshold such as a threshold corresponding to 2 micro volts above abaseline output from the muscle(s) at rest.

There are numerous measurements related to the graph 62 that may bedetermined to be effective for predicting patient disorders (i.e.,diagnosing a patient's symptom(s)), and various calibration or trainingprocesses may be used to determine the measurements that are mosteffective in providing an appropriate diagnosis. In addition to themeasurements/characteristics of the BCR patient data received from thesignal conversion process 48, some additional measurements that may beuseful in diagnosing a patient's symptoms are: the integral of thegraphical signature 68, the number or magnitude of local minima ormaxima, an extent of the graphical signature 68 below/above apredetermined value, etc.

In one embodiment of the presently disclosed system and method forscreening, instead of (or in addition to) hypothesizing/diagnosingvarious disorders/symptoms, any of the above mentioned statistics orcharacteristics of the graphical signature 68 may be computed from theBCR digital data streams, and then output to a technician, nurse orphysician for review and interpretation.

In one embodiment of the screening system and method, one or more of thefollowing assessments may be obtained from analysis of the BCR timeseries measurements generated by the signal conversion process 48:

-   -   (a) the patient's spinal cord segments S2 through S4 are in        tact,    -   (b) there may be lesions in the cauda equine,    -   (c) an indication of actual chronic back pain, e.g., as asserted        by the patient,    -   (d) the latency between genital stimulation and the resulting        bulbocavernosus reflexes are within a normal range and are not        indicative of neurological order (e.g., contrary to what is        asserted by the patient),    -   (e) the latency between genital stimulation and the resulting        bulbocavernosus reflexes are abnormal and are indicative of        neurological order,    -   (f) the BCR time series measurement are indicative of a voiding        dysfunction, bowel dysfunction, and/or    -   (g) the time series measurements are indicative of a male        impotence condition.

A report may be generated by the analysis process 60, and the report canbe printed for entry into the patient's medical records, wherein thereport may include any of the information disclosed hereinabove.

Another embodiment of the probe is shown in FIGS. 3 and 4, whereincomponents that functionally correspond to components of probe 10described hereinabove are identified by the same numerical label exceptwith an “a” following. Accordingly, the probe is identified by the label“10 a”.

One or more of FIGS. 3 and 4 show:

-   -   (i) a handle 11 a for holding the probe 10 a,    -   (ii) a piezoelectric disk 12 a for at least detecting a        mechanical pressure from the tip 34 a for stimulating a        patient's penis or clitoris in a similar manner as discussed        hereinabove.    -   (iii) a stimulus plunger 13 a for transferring toward the        piezoelectric disk 12 a a resulting mechanical movement of the        tip 34 a contacting the patient's penis or clitoris; in        particular, the plunger 13 a includes the tip 34 a, and an        opposing end 30 a,    -   (iv) a plunger housing 14 a which is operatively attached to an        end of the handle 11 a for retaining at least part of the        stimulus plunger 13 a therein; note that as with the plunger        housing 14 of the probe 10, the plunger housing 14 a includes an        opening or bore 22 a through which the shaft 18 a of the        stimulus plunger 13 a extends, and the stimulus plunger 13 a (as        with the stimulus plunger 13) includes an expanded portion 24 a        that prevents the plunger from slipping entirely through the        opening 22 a,    -   (v) a compression spring 15 a for separating the stimulus        plunger 13 a from the piezoelectric disk 12 a; in particular,        the end 70 of the spring 15 a fits onto an end 74 of the        pressure transfer rod 78, and the spring end 82 contacts the        opposing end 30 a of the plunger 13 a within the channel 84        extending the length of the handle 11 a.

When the probe 10 a is fully assembled, the piezoelectric disk 12 a issandwiched between washers 86 a,b (preferably plastic). The disk 12 aand washers 86 are contained within an interior 90 of the piezohousing94 which is secured to the end 98 of the handle 11 a by, e.g., adhesive,mating threads, a snap fit, or another comparable securing mechanism. Anendcap 102 seals the disk 12 a and the washers 86 a and 86 b within theinterior 90 by, e.g., snapping the semi-annular locking projections 106onto the ridge or recess 110 adjacent the opening 114 of the interior90. Additionally retained in the interior 90 is a tapered compressionspring 118 which provides a pressure on the piezoelectric disk 12 a atall times. When the pressure transfer rod 78 is positioned in thechannel 84, the expanded head 122 rests against the center opening inthe washer 86 a, but the expanded head is too large to fit through thisopening.

During operation of the probe 10 a, an operator activates the probe 10 aby, e.g., a quick downward (preferably at least somewhat unanticipated)pressure of the stimulus tip 34 a on the clitoris or penis. In oneembodiment, when electrical power is already being supplied to the disk12 a from an electrical power source, e.g., a battery 17 a (preferablypositioned between the disk 12 a and the washer 86 b) within the handle11 a, or an exterior electrical power supply (not shown), suchactivation of the probe by contacting a patient's genital area causesthe end 74 of the transfer rod 78 and the opposing end 30 a to come incontact (or otherwise become configured for the transfer of tip 34 amovement). Accordingly, the movement of the tip 34 a toward the interiorof the plunger housing 14 a causes movement of the transfer rod 78 forincreasing pressure on the disk 12 a, wherein such increased pressureresults in an additional electrical charge to develop on the surface ofthe piezoelectric disk. Since the disk 12 a is electrically connected tothe amplifier 36 (via a connection not shown, and the external conductor38 a), the electrical charge induced on the disk is detected by theamplifier for amplification. Thus, the disk 12 a functions as a sensorfor detecting contact between a patient and the tip 34 a. However, notethat alternative embodiments of sensors may be used to detect thetransfer of pressure from the tip 34 a to the disk 12 a. In particular,the opposing end 30 a may include a pressure sensitive switch (notshown) for detecting contact with the disk 12 a.

Alternatively, such activation of the probe 10 a by contacting apatient's genital area may initiate an electrical current from a powersource (e.g., a battery 17 a, or an exterior electrical power supply) tothe piezoelectric disk 12 a thereby causing the disk to apply vibratorypressure to the transfer rod 78 for initiation of the BCR reflex. Thus,when the tip 34 a is pressed against the penis or clitoris, the shaft 18a slides further into the plunger housing 14 a and handle 11 a forthereby compressing the spring 15 a so that vibratory pressure from thedisk 12 a results in mechanical vibrations being transferred to the tip34 a (via the shaft 18 a and the transfer rod 78) for stimulation of thepenis or clitoris.

As with the probe 10, at the time that the vibratory pressure commencesto transfer to the tip 34 a, a mechanical stress caused by the head 122applying additional pressure against the disk 12 a causes an electricalcharge to develop on the surface of the disk. This electrical charge iscommunicated to the external conductor 38 a via an internal conductor(not shown), and subsequently conveyed to the amplifier 36 (e.g., an EMGamplifier) where it is detected, and amplified as described hereinabove.The amplified signal is transmitted to the computer 40 (via transmissioncable 44) as also described hereinabove.

Accordingly, the probe (10 or 10 a) at least provides electrical signalsfor identifying when to commence measuring an electrical response (viathe sensing electrodes 2) to a BCR.

In each of the above embodiments of the probe 10 and 10 a, the includeddisk (or other vibration generating element) may be selected forgenerating vibrations having frequencies in the range of 2 Hz to 20 Hz,and more preferably in the range of 4 Hz to 10 Hz, most preferablyapproximately 5 Hz. In particular, the inventors have determined thatvibrations outside of these ranges have reduced effect on the patient,and/or may be painful.

Note that in addition to activation of the probe (10 or 10 a) bycontacting a patient's genital area, the probe may include an activationswitch (e.g., button switch 124, FIG. 3), wherein pressing (or otherwisemanipulating) such a switch induces a current to flow to the disk 12 afor providing an electrical potential to the disk. Such a switch mayonly activate the electrical features of the probe, and not be capableof turning off such features. Accordingly, as described hereinabove, abattery powered embodiment of the probe may be used for only aprescribed time before becoming non-functional due to, e.g., one or moredead batteries. However, other mechanisms may also be used forprohibiting the reuse of the probe with another patient. For example, adeactivation timer may be incorporated into the probe.

Note that for embodiments of the probe wherein the included disk remainsin a vibratory active state once the probe is powered on, suchvibrations (or lack thereof) can be an indicator to an operator as towhether the probe has been previously used. For example, if uponactivation of the activation switch, the operator senses no vibratoryresponse from the disk 12 or 12 a (e.g., due to a dead battery, and/ordue to detection that the activation switch has been previously used topower the probe, etc.), then the operator will be alerted that the probeis at least non-functional and may have been used previously.

Moreover, at least some embodiments, the probe (10 or 10 a) may includea light emitting diode to notify an operator that the probe has not beenpreviously used. For example, for a functional probe that had not beenpreviously activated, such a diode would be activated when the buttonswitch 124 is pressed for electrically activating the probe, and such adiode would emit light until a predetermined probe state occurs thatdeactivates the probe and prevents the probe from being reactivated.

Embodiments of the probe (10 or 10 a) may also prohibit their reusebased not only on an elapsed time, but also on the number of times theprobe tip is depressed toward the interior of the probe housing. Forexample, by providing no more than, e.g., five probe tip depressionwithin a predetermined maximal elapsed time of probe activation,additional assurance that the probe will not be reused with anotherpatient can be provided.

Referring now to FIG. 6, a more detailed diagram of an embodiment of thescreening system and method is disclosed. The components (andcommunications therefor) described in FIG. 6 that have substantiallyidentical functionality with components described hereinabove areidentified by the number of the component described above followed by“x”. Moreover, an embodiment of the probe 10 x shown in FIG. 6 may beone of: probe 10 or 10 a, or another embodiment. The components,communications, and data processing of the embodiment of FIG. 6 aredescribed in the following sections (1) through (7).

(1) Description of the Components Shown in the Embodiment of FIG. 6.

-   -   (1-1) A Bulbocavernosus Reflex Stimulation (BRS) External Power        Supply 104 is a medical grade power supply that is used to        supply 24 volt DC power to the BRS Module 108 (described        hereinbelow).    -   (1-2) A probe 10 x is used to administer and measure the genital        stimulation in a manner as described in previous embodiments        hereinabove. The tip 34 x in the probe 10 x may be replaceable        and may contain an ID chip 112. The ID chip 112 is used to        prevent its tip 34 x from being used more than once (e.g.,        prevented from being used on more than one patient) as is        described further hereinbelow. Thus, instead of the entire probe        10 x being non-reuseable on different patients, only the probe        tip 34 x is non-reuseable. The probe 10 x interfaces to the BRS        Module 108 (which includes an amplifier/filter 36 x having        substantially identical function to the combination of the SEMG        35 and the amplifier 36 disclosed in FIG. 1 and described        hereinabove). In particular, the amplifier/filter 36 x includes        a surface EMG amplifier/filter 116 for receiving signals from        the electrodes 2, and a stim(ulus) probe amplifier 120 for        receiving signals indicative of probe 10 x activation (via cable        38 x. Both amplifiers 116 and 120 are described hereinbelow.    -   (1-3) The ID chip 112 provided in the probe tip 34 x can output        data to the BRS module 108 for determining whether the probe tip        has been previously used to contact a patient, and if so, the        elapsed time since this first use. In one embodiment, such data        includes a time and date that the probe 10 x was first        activated, or if not previously used such data may include a        predetermined value such as zero. Thus, the ID chip 112 includes        a non-volatile data storage for storing data indicative of the        probe tip's activation history (which may be only the initial        date and time of, if any, the probe tip's first activation). In        one embodiment, such activation history may include the time and        date of each activation, and/or the elapsed time of each        activation. Note that the ID chip 112 may be activated each time        the probe 10 x is operably connected to the BRS module 108. In        particular, data is communicated on the conductors 160 a and 160        b from the MCU 128 processor (described below) for activating        the ID chip 112 so that it will respond to the MCU with an        acknowledgement of whether the probe tip 34 x can or cannot be        used for a subsequent patient contact. Accordingly, an        acknowledgement by the ID chip 112 that the probe tip 34 x        cannot be used will cause the MCU 128 to issue commands to at        least prevent data collection from the probe 10 x, and        preferably provide an indication to the operator that the probe        having this tip cannot be used for such data collection. There        are various ways to provide such an indication of probe non-use,        e.g., visual display on the BRS module 108 may be used such as a        red LCD may light when the probe cannot be used, and a green LCK        may light when the probe can be used. Alternative/additional        visual and/or auditory presentations are also within the scope        of the present disclosure. Accordingly, iconic and/or textual        information can be visually presented to an operator for        indicating whether the probe 34 x (with its current probe tip 34        x) can be operably used. Alternatively/optionally, synthetic        speech or various sounds may be used for indicating whether the        probe 34 x (with its current probe tip 34 x) can be operably        employed.    -   (1-4) The BRS Module 108 is the interface unit between the BRS        Computer 40 x and both the patient applied probe 10 x and EMG        leads (collectively labeled as 46 x in FIG. 6).        Subsystems/components of the BRS Module are as follows:        -   (1-4.1) Micro Controller Unit (MCU) 128.            -   The MCU 128 is a microprocessor that controls and                monitors data and communication in the BRS Module 108.                The MCU 128 contains firmware for the following                functions:                -   a. Connects and communicates with the BRS computer                    40 x via the USB interface 132.                -   b. Upon command the MCU 128, collects digital data                    from the surface EMG analog to digit converter 136                    (which converts the amplified voltage differences                    from the electrodes 2 to digital data), and the Stim                    Probe analog to digital converter 140 (which                    converts the amplified probe activation signal to                    digital data). The MCU 128 then sends such digital                    data to the BRS computer 40 x via the USB interface                    132,                -   c. Monitors the 24 volt power supply 104 and                    communicates the status of this power supply to the                    BRS computer 40 x via the USB interface 132.                -   d. Reads and updates the IC chip 112 in the Stim                    Probe Tip 34 x to ensure that the Probe Tip is not                    used for more than 30 minutes.        -   (1-4.2) Isolation DC/DC Converters 144.            -   The Isolation DC/DC converters 144 supply isolated                −3.3V, +3.3V, and 5V DC power to the patient connected                components; in one embodiment such converters may be: a                Datel UWR-5/2000-D24E-C Murata NDTD0503C or similar                components as one of ordinary skill in the will                understand.        -   (1-4.3) Isolation Barrier 148.            -   The Isolation Barrier 148 provides the necessary                creepage and clearance distances between the AC mains                connected power and patient connected power.        -   (1-4.4) Power Detector 152.            -   The power detector 152 is used by the microprocessor MCU                128 to monitor the state of the 24 Volt Power supply                from the power supply 104.        -   (1-4.5) Digital Optical Isolators 156.            -   The Digital Optical Isolators 156 are used to provide                isolation between the patient connected electronics                (i.e., the electrodes 2 and 4), and USB powered                electronics (i.e., the computer 40 x). The optical                isolators 156 allow the MCU 128 to communicate with the                analog to digital converters 136 and 140, and the chip                112 in the Stim Probe Tip 34 x via a one wire interface                provided by the conductors 160 a and 160 b.        -   (1-4.6) Stim Probe Amplifier/Filter 120.            -   The Stim Probe Amplifier/Filter 120 amplifies and                filters the signal from the Stim Probe 10 x to a level                that can be read by the A/D converter 140. The MCU 128                controls the analog to digital conversion process of the                A/D converter 140.        -   (1-4.7) Stim Probe A/D (Analog to Digital) Converter 140.            -   The A/D converter 140 is an analog to digital converter                for changing the incoming amplified Stim Probe 10 x                signal into a digital value for the MCU 128 to read and                then send to the computer 40 x for analysis. The MCU 128                controls the A/D conversion process of the A/D converter                140.        -   (1-4.8) Surface EMG Amplifier/Filter 116.            -   The Surface EMG Amplifier/Filter 116 amplifies and                filters the voltage signals from the electrodes 2 to a                level that can be read by the A/D converter 136.        -   (1-4.9) Surface EMG A/D (Analog to Digital) Converter 136.            -   The converter 136 is an analog to digital converter for                changing the incoming amplified Surface EMG signal into                a digital value for the MCU 128 to read and send to the                computer 40 x for analysis.        -   (1-4.10) Signal Conditioner 164.            -   The signal conditioner 164 translates the two wire                interface 160 a from the MCU 128 to/from the 1 wire                interface 160 b which communicates with the ID chip 112.    -   (1-5) Computer 40 x.        -   The computer 40 x provides a user interface for displaying,            e.g., displays such as shown in FIG. 5 described            hereinabove. The computer 40 x communicates with the BRS            Module 108 through the USB interface 132. The computer 40 x            contains a custom application for at least the following            functions:            -   a. Communicates and receives status information from the                BRS Module 108 regarding power on (more generally                activation status), information for obtaining probe tip                ID chip 112 information (e.g., BCR time series values,                ID chip status, etc).            -   b. Sends commands to the BRS Module 108 to acquire data                from the Stim probe 10 x.            -   c. Graphs and/or analyses data from the Surface EMG data                channel (which includes the components 116, 136, 156,                and 128), and from the Stim Probe data channel (which                includes the components 10 x, 38 x, 120, 140, 156, and                128) for presentation to an operator. The graphs and/or                analysis performed may be as described hereinabove                regarding the analysis process 60 (FIG. 1) and the user                interface of FIG. 5.            -   d. Processes the Stim probe 10 x signal to determine the                time of commencement of patient stimulation.            -   e. Allows an operator to input patient and physician                information.            -   f. Stores test case data for later review and analysis.            -   g. Prints reports is instructed by an operator.    -   (1-6) Printer 168.        -   The printer 168 is used by the Computer 40 x to print            reports on patient cases.

(2) High Level Processing of Data in the BRS Module 108.

-   -   For each of the EMG data channel (which includes the components        116, 136, 156, and 128), and the Stim Probe data channel (which        includes the components 10 x, 38 x, 120, 140, 156, and 128) the        high level algorithm used to process incoming analog data can be        simplified down to:        -   (a) first inputting the analog data to an amplifier and a            high pass filter (provided by the components 116 and 120),            followed by a RMS detector process (provided by the A/D            converters 136 and 140), and        -   (b) providing the output from (a) immediately above to a            process (provided by the computer 40 x), wherein the data is            decimated down from a 2 KHz sample rate to a 1 KHz sample            rate by simply saving every other sample.    -   The signal provided by each of the above-identified channels        passes through its own filter and RMS detector and decimator        before being stored in the computer 40 x (or a database operably        connected thereto).    -   (2-1) Implementation.        -   Each high pass filter is implemented as a 4 pole Butterworth            filter having a cutoff frequency of 10 Hz and a pass band            ripple of 0%. Each RMS detector is implemented using the            Root Mean Square algorithm for a finite number of sequential            samples.

(3) Filter Algorithm

-   -   Each filter used in the amplifier/filter 36 x may be a Chebyshev        filter optimized for a pass band ripple of 0%, otherwise known        as a Butterworth filter. Each of the filter is a form of        recursive filter, which is also called an IIR (Infinite Impulse        Response) filter. For a detailed description of recursive        filters and the implementation see the Scientists and Engineers        Guide to Digital Signal Processing chapters 19 and 20, by        Steven W. Smith, published by California Technical Publishing.    -   (3-1) Implementation.        -   Each of the filters utilizes an embodiment of the following            equation, as one of ordinary skill in the art will            understand.            y[n]=a ₀ x[n]+a ₁ x[n−1]+a ₂ x[n−2]+a ₃ x[n−3]+ . . . +a            _(n) x[0]+b ₁ x[n−1]+b ₂ x[n−2]+b ₃ x[n−3]+ . . . +b _(n)            x[0],    -   wherein for 0≦i≦n, a_(i) is the recursion coefficient of the        incoming signal, b_(i) is the recursion coefficient of previous        output signals, x[i] is the incoming signal, and y[i] is the        output signal.

(4) RMS Algorithm

-   -   The RMS (Root Mean Square) is a measure of the magnitude of a        varying quantity (e.g., a signal), which is calculated for a        series of discrete values for a continuously varying function.        The BRS software uses the RMS algorithm to transform the        incoming signals into a magnitude (as opposed to a wave) so that        the analysis by an operator easier. The period of the function        is configurable by the operator. For a more detailed description        of the RMS algorithm see http://en.wikipedia,org/wiki/Root_mean        square.

(5) Stimulation Marker Detector Algorithm.

-   -   The Stimulation Marker Detector algorithm scans the stimulation        probe time series (received via the cable 38 x) looking for a        change in signal amplitude of 1%±0.1% within a 50-millisecond        window. If/when a change in amplitude at t+50 that exceeds this        threshold is detected, a marker is placed in the data stream of        the Stim Probe data channel, wherein the marker corresponds to        time t. If a marker is detected, this algorithm is blacked out        for a period of 1.5 seconds.    -   (5-1) Implementation    -   For each sample in the time-record (minus 50 mS) perform the        following steps:        -   (5-1.1) Scan ahead of current position up to 50 mS;        -   (5-1.2) If the magnitude of the stimulus signal meets            criteria, place a marker in the data stream of the Stim            Probe data channel;        -   (5-1.3) Black out additional marker placement for 1.5            seconds

From the disclosure hereinabove, and the accompanying figures, it isbelieved that one of ordinary skill could manufacture the presentscreening system, and in particular, the probe (10 and/or 10 a). Moreparticularly, FIGS. 1 and 3 are believed to provide effectiveindications as to how the components of the embodiments of the probewould be assembled.

The novel system and method disclosed herein is valuable in evaluationof urinary disorders in adults and children, as well as erectiledysfunction when neurological etiology is suspected. While variousembodiments of the present disclosure have been described in detail, itwill be apparent that further modifications and adaptations of theembodiment disclosed herein will occur to those skilled in the art. Itis to be expressly understood that such modifications and adaptationsare within the spirit and scope of the present disclosure.

What is claimed is:
 1. A non-surgically implantable method for measuringa bulbocavernosus reflex, comprising: a probe a patient contactingportion configured for being brought into contact with a predeterminedbody area of a patient with sufficient force for inducing, via amechanical stimulation of the predetermined body area from the force, areflex of bulbocavernosus muscle, said probe comprising; (i) a housingwith a bore there through, said housing containing a piezoelectric disk,said disk electrically connected to an amplifier and activated by apower source; (iii) a patient contacting portion comprises stimulusplunger having first and second ends and having a shaft that extendsthrough the bore, said shaft being movable along a longitudinal axis andhaving an expanded portion that prevents the stimulus plunger fromsliding our of an opening in the housing; and (iii) a compression springthat biases said second end of the stimulus plunger away from contactwith the piezoelectric disk; wherein the patient contacting portion isconfigured to activate, during the contact, the piezoelectric disk inthe probe resulting in a signal response that identifies when an onsetof the contact of the predetermined body area occurs; wherein the signalresponse is used in identifying a subsequent collection of electricalresponses from a plurality of electrodes placed on the patient's skin,wherein the collection is indicative of the bulbocavernosus musclereflex or an absence thereof; wherein the placed plurality of electrodesare spaced apart from each of: (i) an additional electrode for supplyinga voltage to the patient's skin, and (ii) the predetermined body areacontacted by the patient contacting portion for inducing thebulbocavernosus muscle reflex; wherein one or more characteristics ofthe electrical responses in the collection provide information about thebulbocavernosus muscle reflex; wherein the characteristics aredetermined using at least one of (a) through (d) following: (a) a timedelay between the response and the collection are output withinformation, (b) a time duration for the collection, (c) a valueindicative of a magnitude of at least one electrical response of thecollection, and (d) a voltage differential between the electricalresponses of the collection and a voltage indicative of thebulbocavernosus muscle substantially at rest.
 2. The apparatus of claim1, wherein: (i) the predetermined body area includes the patient's penisor the patient's clitoris, (ii) the characteristics are determined usingat least most of (a) through (d), and (iii) the apparatus includes acomputer for determining the characteristics, and an electronic displayfor displaying a graphical representation of the collection in graphicalrelation to a time of the signal response.
 3. The apparatus of claim 1,wherein the piezoelectric disk is an electrical switch, wherein thesignal response is a result of a mechanical effect of the contact on thepiezoelectric disk for changing an electrical property thereof.
 4. Theapparatus of claim 2, wherein the piezoelectric disk is an electricalswitch.
 5. The apparatus of claim 4, wherein the force affects anelectrical property of the piezoelectric disk.
 6. The apparatus of claim2, wherein for determining the characteristics, a voltage differencebetween two of the plurality of electrodes is determined.
 7. Theapparatus of claim 1, wherein the contact is non-invasive.
 8. Theapparatus of claim 1, wherein the first and second of the electrodes areplaced on opposite sides of the patient's rectum, and adjacent thereto.9. The apparatus of claim 1, wherein the patient contacting portion isseparable from the remainder of the probe so that the probe is operablyreusable when a different patient contacting portion is includedtherein, wherein each one of the patient contacting portion and thedifferent patient contacting portion includes electronics for use inpreventing a reuse of the one patient contacting portion; wherein theelectronics includes a data storage for identifying one of: (i) if thepatient contacting portion therefor has been previously used with theprobe for contacting a patient for inducing the bulbocavernosus reflex,and (ii) a length of time the patient contacting portion therefor hasbeen activated by the probe.
 10. The apparatus of claim 1, wherein theprobe includes a data store for storing data indicative of a history ofactivation of the probe.
 11. The apparatus of claim 10, wherein the datastore is included in the patient contacting portion, and the patientcontacting portion is movable relative to the housing when the force isapplied to the predetermined body area.
 12. The apparatus of claim 1,further including an analysis process for activating at least onepredictive model, wherein upon receiving the characteristics, the atleast one predictive model determines a correspondence between (i) thecharacteristics, and (ii) one of the following disorders: a neurologicaldisorder, a sexual disorder, and a voiding dysfunction wherein thecorrespondence is determined according to a similarity between thecharacteristics and previously collected data indicative of thedisorders.
 13. The apparatus of claim 12, wherein the at least onepredictive model determines a similarity between the characteristics,and one or more predetermined associations between a patient diagnosis,and collected information representative of (a) through (d) obtainedfrom other patients.
 14. The apparatus of claim 1, wherein theinformation is representative of (a).
 15. The apparatus of claim 1,wherein the information is representative of (b).
 16. The apparatus ofclaim 1, wherein the information is representative of (c).
 17. Theapparatus of claim 1, wherein the information is representative of (d).18. The apparatus of claim 1, wherein the vibratory assembly vibrates ina range of 2 Hz to 20 Hz.